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(Sr) Safety Reporting Specialist (R1042545) in Morrisville, NC at IQVIA™

Date Posted: 12/3/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    12/3/2018
  • Job ID:
    R1042545

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Novella Clinical is seeking a (Senior) Safety Reporting Specialist (Home or Office-Based):

BASIC FUNCTION:

Delivers global safety reporting services including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MD) according to ICH-GCP guidelines, regulatory requirements and Novella Standard Operating Procedures (SOPs) and/or project specific procedures.  

Primary responsibilities include:
 

  • Review, preparation and submission of safety reports (Expedited and Periodic) to all applicable Competent Authorities and Central Ethics Committees within defined timelines for drug clinical trials and medical device clinical investigations.
  • Generation and maintenance of the global safety reporting plan for individual studies.
  • Oversight of third party vendors and timely compliance reconciliation of vendor submissions.
  • Handle EudraVigilance user registration and maintenance
  • Serve as Responsible Person for Eudravigilance, if assigned

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Maintains a high level of understanding of applicable safety reporting regulations (FDA and ICH guidance, GCP regulations, EU Directives, country specific requirements etc.).
  • Assists in the maintenance of the safety reporting regulatory intelligence repository and informing the Safety Management team and project teams of any pertinent updates.
  • Submits expedited and periodic safety reports to Sponsors, Competent Authorities and Ethics Committees as applicable according to Novella SOPs and the project specific safety reporting plan including any country specific reporting requirements.
  • Distributes final regulatory reports to Clinical Operations or designee for reporting to Investigators or local IRBs/ECs.
  • Submits ICSRs electronically through EVWeb or gateway.
  • Prepares and submits EudraVigilance documents related to user registration and maintenance
  • Assumes all applicable responsibilities as required for the role of “Responsible Person for EudraVigilance”
  • Liaises with applicable departments at Novella and/ or the client to ensure timely submission of Expedited and Periodic reports to applicable Regulatory Authorities and Ethics Committees and ensure all submissions are tracking appropriately and maintained in the project folders.
  • Communicates with Competent Authorities and EMA/Eudravigilance on administrative and routine matters related to electronic safety reporting.
  • Provides input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.
  • Maintains awareness of reporting timelines for aggregate safety reports.
  • Tracks regulatory submissions in the safety database or project specific tracking tool, as applicable.
  • Assists in conducting root cause analysis for any late regulatory reports.
  • Performs vendor compliance reconciliation as required per project
  • Attends internal and client project team meetings and provides relevant team updates as required.
  • Assists management with, or takes ownership of, writing processes and developing documents related to safety reporting, including study-specific processes.
  • Develops processes and writes documents related to safety reporting, including study-specific processes.
  • Supports departmental process improvement initiatives and collaborates with relevant departments to ensure execution.
  • Supports business development activities, budget, and proposal input, etc., as required.
  • Mentors and/or trains other safety reporting staff, as applicable.
  • Performs other duties as assigned by the Manager, Safety Reporting or above.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute safety reporting activities.
  • Excellent written and verbal communication skills.
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
  • Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
  • Advanced ability to understand, evaluate and follow regulatory legislation and guidelines.
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative.
  • Excellent knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
  • Good knowledge of Medical Device regulations, both pre-and post-marketing.
  • Excellent knowledge of electronic safety databases (preferable including Argus).
  • Excellent knowledge of electronic safety reporting systems (e.g. EudraVigilance, safety database gateway).
  • EudraVigilance certification preferred.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very limited physical effort required to perform normal job duties.
  • Ability and willingness to travel domestically and internationally, if required (travel requirement <5%).

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s Degree in one of the life sciences or clinical research and a minimum of 5 years of related pharmacovigilance experience and at least 2 years of relevant safety submission experience.
  • Previous experience in medical device trials preferred.
  • Appropriate clinical research experience including electronic data management systems, EDC, safety database usage (Argus experience preferred).
  • Excellent knowledge of issues affecting Safety/Pharmacovigilance reporting for clinical trials of IMPs and medical devices.
  • Prior experience with Eudravigilance submissions preferred.
  • Computer literacy and experience working with Microsoft Office (Word, Excel, and PowerPoint) required.
  • Good interpersonal and organization skills required.
  • Ability to work independently, prioritize effectively and work within a matrix team environment.

CLASSIFICATION (US):

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1042545